BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN

    MDR report key: 4342696 · Received December 12, 2014

    Report

    Report Number
    MW5039631
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 25, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LAPAROSCOPIC COLECTOMY. DURING THE SURGERY, THE NON-NACTIOPAGUE FLEXIBLE INSULATION ON THE (B)(4) CAME LOOSE AND FOLDED BACK UPON ITSELF. THIS WAS THE SECOND ISSUE IN WHICH WE FOUND AN ISSUE WITH THIS SILICONE INSULATION. IT WAS REPORTED TO THE SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808097 COVIDIEN LIGASURE ADVANCE, LF5034 GEI COVIDIEN LF5544 42471185Y

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other